ClinicalTrials.gg
TerminatedNCT03955146Updated Sep 19, 2024Results posted

Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

A Phase 3 interventional study of Pamrevlumab and Placebo in Idiopathic Pulmonary Fibrosis, sponsored by FibroGen. Terminated at 125 sites in 9 countries. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by FibroGen · Phase 3, Interventional, and Treatment

Why this study was terminated
Study did not meet its primary endpoint.
Phase
Phase 3
Study type
Interventional
Enrollment
393
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 236 studies in Idiopathic Pulmonary Fibrosis with a site in United States — 37 open to participants now, 51 under way, 8 of them phase 3. Idiopathic Pulmonary Fibrosis · United States.

Enrollment
23rd of 188
393 · median 61
Started
2019
with 10 others
Phase 3
37 of 236
6 open now
Registered
138th of 236
by date
Lead sponsor
5 of 236
FibroGen

Among the 236 studies in Idiopathic Pulmonary Fibrosis with a site in United States, this one is the 23rd largest by enrollment of the 188 interventional ones that give a count, is one of 11 that started in 2019, is one of 37 in phase 3, and was the 138th registered.

Idiopathic Pulmonary Fibrosis

577 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 124 are open to participants now.

Browse Idiopathic Pulmonary Fibrosis studies →

Open to participants now

37 of the 236 studies in Idiopathic Pulmonary Fibrosis with a site in United States are open now. Recruiting first, the newest first:

32 more — sign in →

All 37 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 86 Idiopathic Pulmonary Fibrosis studies recruiting now, 56 (65%) set no upper age limit and 8 (9%) stop at 75 or younger; 3 take children under 18; 15 take healthy volunteers.

This study: 40 Years to 85 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 236 studies in Idiopathic Pulmonary Fibrosis with a site in United States, or all of them as a file.
02

Study summary

This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with IPF.

Read the detailed description

This is a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to evaluate the efficacy and safety of pamrevlumab in participants with IPF.

Participants who are not being treated with approved IPF therapies (that is, nintedanib or pirfenidone) may be eligible for screening. Examples of reasons participants may not be treated with approved IPF therapies include but are not limited to:

  • Intolerant or not responsive to approved IPF therapies
  • Ineligible to receive these therapies
  • Participant voluntarily declines to receive approved IPF therapies after being fully informed of the potential benefits/risks

NOTE: No participant should discontinue an approved IPF therapy for the purpose of enrolling in this study.

The study consists of the following study periods:

  • Main (double blind, placebo-controlled) phase:

    • Screening period: Up to 6 weeks
    • Treatment period: 48 weeks
  • Optional, open-label extension (OLE) phase of pamrevlumab:

    o Access to pamrevlumab will be available until the last participant completes 48 weeks of treatment in the OLE phase, or pamrevlumab is commercially available for the indication of IPF, or the Sponsor decides to end the OLE phase, whichever occurs first.

  • Follow-up period/final safety assessments:

    • 28 days after last dose
    • 60 days after last dose: follow-up phone call, for a final safety assessment

During the treatment period, co-administration of an approved IPF therapy (that is, pirfenidone or nintedanib) is acceptable if clinically indicated in the Investigator's opinion, provided that the Investigator assesses the potential risks/benefits of combining approved IPF therapies with blinded study treatment.

Participants who discontinue study treatment for any reason should be encouraged to remain in the study and be followed for all study visits and assessments.

Participants who complete the Week 48 visit of the main study (regardless of the number of study drug infusions received) will be eligible to participate in the optional OLE phase of the study that offers continuing access to pamrevlumab regardless of randomization assignment in the main study.

03

Conditions studied

  • Idiopathic Pulmonary Fibrosis

Keywords

  • Idiopathic Pulmonary Fibrosis, IPF, Idiopathic Interstitial Pneumonia, Interstitial Lung Disease, Lung Fibrosis
04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Diagnosis of IPF as defined by American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japan Radiological Society (JRS)/Latin American Thoracic Association (ALAT) guidelines within the past 7 years prior to study participation.
  2. High-resolution computed tomography (HRCT) scan at screening, with ≥10% to \<50% parenchymal fibrosis (reticulation) and \<25% honeycombing.
  3. FVCpp value >45% and \<95% at screening and Day 1 (prior to randomization).
  4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted and corrected by (Hb) value ≥25% and ≤90% at screening (determined locally).
  5. Not currently receiving treatment for IPF with an approved therapy (that is, pirfenidone or nintedanib) for any reason, including prior intolerance or lack of response to an approved IPF therapy, or choice to forego treatment with an approved IPF therapy after a full discussion with the Investigator regarding risks/benefits of such therapy.

Key Exclusion Criteria:

  1. Previous exposure to pamrevlumab.
  2. Evidence of significant obstructive lung disease.
  3. Female participants who are pregnant or nursing.
  4. Smoking within 3 months of screening and/or unwilling to avoid smoking throughout the study.
  5. Interstitial lung disease other than IPF.
  6. Sustained improvement in the severity of IPF during the 12 months prior to screening.
  7. History of other types of respiratory diseases including diseases or disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall.
  8. Medical conditions (for example, myocardial infarction [MI]/stroke within the past 6 month), or logistical challenges that in the opinion of the Investigator preclude the participant's adequate participation in the study.
  9. Acute IPF exacerbation during screening or randomization.
  10. Use of any drugs or unapproved therapies, or participation in any clinical trial with an investigational new drug within 30 days prior to screening. Or use of approved IPF therapies (that is, pirfenidone or nintedanib) within 1 week prior to screening.
  11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies, or to any component of the .
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
393 participants (actual)

Study arms

  • Experimental
    Main Study Cohort: Pamrevlumab

    Participants will receive pamrevlumab 30 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion every 3 weeks for up to 48 weeks in the DB period.

    Drug: Pamrevlumab

  • Placebo comparator
    Main Study Cohort: Placebo

    Participants will receive placebo matching to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks in the DB period.

    Drug: Placebo

  • Experimental
    Japan Extension Cohort: Pamrevlumab

    Participants will receive pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.

    Drug: Pamrevlumab

  • Placebo comparator
    Japan Extension Cohort: Placebo

    Participants will receive placebo matching to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.

    Drug: Placebo

  • Experimental
    OLE Period: Pamrevlumab/Pamrevlumab

    Participants who receive pamrevlumab in the DB period will continue to receive the same dose of pamrevlumab for up to 48 weeks in the OLE period or until pamrevlumab is commercially available for the indication of IPF, or the sponsor decides to end the OLE period, whichever occurrs first.

    Drug: Pamrevlumab

  • Experimental
    OLE Period: Placebo/Pamrevlumab

    Participants who receive placebo matching to pamrevlumab in the DB period, will receive pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks in the OLE period or until pamrevlumab is commercially available for the indication of IPF, or the sponsor decides to end the OLE period, whichever occurrs first.

    Drug: Pamrevlumab

Interventions

  • Pamrevlumab will be administered per dose and schedule specified in the arm description.

    Also known as: FG-3019

  • DrugPlacebo

    Placebo matching to pamrevlumab will be administered per schedule specified in the arm description.

06

What researchers measure

Primary outcomes

  1. DB Period (Main Study Cohort): Change From Baseline in FVC at Week 48

    FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that could forcibly be blown out after full inspiration in the upright position, measured in liters. Least square (LS) mean and standard error (SE) were calculated using mixed model for repeated measures (MMRM).

    Time frame: Baseline, Week 48

  2. DB Period (Japan Extension Cohort): Change From Baseline in FVC at Week 48

    FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that could forcibly be blown out after full inspiration in the upright position, measured in liters.

    Time frame: Baseline, Week 48

Secondary outcomes

  1. DB Period (Main Study Cohort): Time to Disease Progression

    Time to disease progression was defined as the number of weeks from randomization to either the first occurrence of an absolute ≥10% decline from baseline in percent predicted FVC (FVCpp) or all-cause death, whichever occurred first. Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.

    Time frame: Up to Week 48

  2. DB Period (Main Study Cohort): Time to First Occurrence of Any Component of the Clinical Composite Endpoint

    The components of the clinical composite endpoint included acute IPF exacerbation, respiratory hospitalization, or death. Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.

    Time frame: Up to Week 48

  3. DB Period (Main Study Cohort and Japan Extension Cohort): Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48

    The QLF volume was calculated as QLF = total lung capacity volume multiplied by percentage (%) of quantitative lung fibrosis for fibrosis of the whole lung. LS mean and SE was calculated using MMRM.

    Time frame: Baseline, Week 48

  4. DB Period (Main Study Cohort): Time to First Acute IPF Exacerbation

    Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.

    Time frame: Up to Week 48

  5. DB Period (Main Study Cohort): Time to All-Cause Mortality

    Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.

    Time frame: Up to Week 48

  6. DB Period (Main Study Cohort): Time to First Respiratory Hospitalizations

    Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.

    Time frame: Up to Week 48

07

Results

Posted Sep 19, 2024
Limitations and caveats
Study did not meet its primary endpoint; hence, it was terminated early. The Japan extension cohort and OLE period were halted due to futility.

Participant flow

DB Period (48 Weeks)
Participant flow — DB Period (48 Weeks)
MilestoneMain Study Cohort: PamrevlumabMain Study Cohort: PlaceboJapan Extension Cohort: PamrevlumabJapan Extension Cohort: Placebo
Started1811751819
Received at least 1 dose of study drug1811751819
Completed1461341411
Not completed354148
Withdrew: Study terminated by sponsor0014
Withdrew: Adverse event2512
Withdrew: Death131710
Withdrew: Investigator decision2200
Withdrew: Disease progression2000
Withdrew: Withdrawal by subject6301
Withdrew: Noncompliance with the study drug1100
Withdrew: Lung transplant0100
Withdrew: Participant decision91211
OLE (Maximum Exposure: 153.1 Weeks)
Participant flow — OLE (Maximum Exposure: 153.1 Weeks)
MilestoneMain Study Cohort: PamrevlumabMain Study Cohort: PlaceboJapan Extension Cohort: PamrevlumabJapan Extension Cohort: Placebo
Started12912300
Received at least 1 dose of study drug12912300
Completed0000
Not completed12912300
Withdrew: Adverse event7100
Withdrew: Death121200
Withdrew: Lost to follow-up0100
Withdrew: Investigator decision2200
Withdrew: Study terminated by sponsor848800
Withdrew: Disease progression1000
Withdrew: Withdrawal by subject7500
Withdrew: Lung transplant2100
Withdrew: Protocol deviation1000
Withdrew: Participant decision121300
Withdrew: Other than specified1000

Outcome measures

PrimaryDB Period (Main Study Cohort): Change From Baseline in FVC at Week 48

FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that could forcibly be blown out after full inspiration in the upright position, measured in liters. Least square (LS) mean and standard error (SE) were calculated using mixed model for repeated measures (MMRM).

Time frame:
Baseline, Week 48
Reported as:
Least squares mean · liters
DB Period (Main Study Cohort): Change From Baseline in FVC at Week 48
litersDB Period (Main Study Cohort) - PamrevlumabDB Period (Main Study Cohort) - Placebo
DB Period (Main Study Cohort): Change From Baseline in FVC at Week 48-0.26 ± 0.046-0.33 ± 0.050
Statistical analysis
  • DB Period (Main Study Cohort) - Pamrevlumab vs DB Period (Main Study Cohort) - Placebo · Mixed Models Analysis · p = 0.2926 · Ls mean difference: 0.07 · 95% CI -0.06 to 0.19
PrimaryDB Period (Japan Extension Cohort): Change From Baseline in FVC at Week 48

FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that could forcibly be blown out after full inspiration in the upright position, measured in liters.

Time frame:
Baseline, Week 48
Reported as:
Mean · liters
DB Period (Japan Extension Cohort): Change From Baseline in FVC at Week 48
litersDB Period (Japan Extension Cohort) - PamrevlumabDB Period (Japan Extension Cohort) - Placebo
DB Period (Japan Extension Cohort): Change From Baseline in FVC at Week 48-0.0445 ± 0.1805-0.1835 ± 0.2389
SecondaryDB Period (Main Study Cohort): Time to Disease Progression

Time to disease progression was defined as the number of weeks from randomization to either the first occurrence of an absolute ≥10% decline from baseline in percent predicted FVC (FVCpp) or all-cause death, whichever occurred first. Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.

Time frame:
Up to Week 48
Reported as:
Median · weeks
DB Period (Main Study Cohort): Time to Disease Progression
weeksDB Period (Main Study Cohort) - PamrevlumabDB Period (Main Study Cohort) - Placebo
DB Period (Main Study Cohort): Time to Disease Progression54.3 (52.7 to NA)50.7 (50.3 to 54.0)
SecondaryDB Period (Main Study Cohort): Time to First Occurrence of Any Component of the Clinical Composite Endpoint

The components of the clinical composite endpoint included acute IPF exacerbation, respiratory hospitalization, or death. Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.

Time frame:
Up to Week 48
Reported as:
Median · weeks
DB Period (Main Study Cohort): Time to First Occurrence of Any Component of the Clinical Composite Endpoint
weeksDB Period (Main Study Cohort) - PamrevlumabDB Period (Main Study Cohort) - Placebo
DB Period (Main Study Cohort): Time to First Occurrence of Any Component of the Clinical Composite Endpoint62.7 (59.0 to NA)NA (57.9 to NA)
SecondaryDB Period (Main Study Cohort and Japan Extension Cohort): Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48

The QLF volume was calculated as QLF = total lung capacity volume multiplied by percentage (%) of quantitative lung fibrosis for fibrosis of the whole lung. LS mean and SE was calculated using MMRM.

Time frame:
Baseline, Week 48
Reported as:
Least squares mean · liters
DB Period (Main Study Cohort and Japan Extension Cohort): Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48
litersDB Period (Main Study Cohort) - PamrevlumabDB Period (Main Study Cohort) - PlaceboDB Period (Japan Extension Cohort): PamrevlumabDB Period (Japan Extension Cohort): Placebo
DB Period (Main Study Cohort and Japan Extension Cohort): Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48251.38 ± 38.010267.96 ± 38.76345.08 ± 88.26578.18 ± 119.300
SecondaryDB Period (Main Study Cohort): Time to First Acute IPF Exacerbation

Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.

Time frame:
Up to Week 48
Reported as:
Median · weeks
DB Period (Main Study Cohort): Time to First Acute IPF Exacerbation
weeksDB Period (Main Study Cohort) - PamrevlumabDB Period (Main Study Cohort) - Placebo
DB Period (Main Study Cohort): Time to First Acute IPF Exacerbation62.7 (62.7 to NA)NA (NA to NA)
SecondaryDB Period (Main Study Cohort): Time to All-Cause Mortality

Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.

Time frame:
Up to Week 48
Reported as:
Median · weeks
DB Period (Main Study Cohort): Time to All-Cause Mortality
weeksDB Period (Main Study Cohort) - PamrevlumabDB Period (Main Study Cohort) - Placebo
DB Period (Main Study Cohort): Time to All-Cause MortalityNA (60.6 to NA)NA (60.1 to NA)
SecondaryDB Period (Main Study Cohort): Time to First Respiratory Hospitalizations

Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.

Time frame:
Up to Week 48
Reported as:
Median · weeks
DB Period (Main Study Cohort): Time to First Respiratory Hospitalizations
weeksDB Period (Main Study Cohort) - PamrevlumabDB Period (Main Study Cohort) - Placebo
DB Period (Main Study Cohort): Time to First Respiratory Hospitalizations62.7 (59.0 to NA)NA (57.9 to NA)

Adverse events

Collected over From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
DB Period (Main Study Cohort): Pamrevlumab23/181 (12.7%)51/181 (28.2%)129/181 (71.3%)
DB Period (Main Study Cohort): Placebo22/175 (12.6%)60/175 (34.3%)121/175 (69.1%)
DB Period (Japan Extension Cohort)Pamrevlumab1/18 (5.6%)5/18 (27.8%)17/18 (94.4%)
DB Period (Japan Extension Cohort): Placebo2/19 (10.5%)8/19 (42.1%)16/19 (84.2%)
OLE Period: Pamrevlumab/Pamrevlumab17/129 (13.2%)42/129 (32.6%)76/129 (58.9%)
OLE Period: Placebo/Pamrevlumab14/123 (11.4%)33/123 (26.8%)75/123 (61%)
Most frequent serious events
Showing 10 of 141
Most frequent serious events
EventDB Period (Main Study Cohort): PamrevlumabDB Period (Main Study Cohort): PlaceboDB Period (Japan Extension Cohort)PamrevlumabDB Period (Japan Extension Cohort): PlaceboOLE Period: Pamrevlumab/PamrevlumabOLE Period: Placebo/Pamrevlumab
Idiopathic pulmonary fibrosisRespiratory, thoracic and mediastinal disorders14/18118/1752/183/1916/12914/123
PneumoniaInfections and infestations8/1818/1751/181/195/1294/123
Metastases to liverNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1810/1751/180/190/1290/123
UrticariaSkin and subcutaneous tissue disorders0/1810/1751/180/190/1290/123
MelaenaGastrointestinal disorders0/1810/1750/181/190/1290/123
PyrexiaGeneral disorders0/1810/1750/181/190/1291/123
Cholecystitis acuteHepatobiliary disorders0/1811/1750/181/191/1290/123
COVID-19Infections and infestations3/1811/1750/181/192/1290/123
DiverticulitisInfections and infestations0/1811/1750/181/190/1290/123
Chemical peritonitisInjury, poisoning and procedural complications0/1810/1750/181/190/1290/123
Most frequent other events
Showing 10 of 99
Most frequent other events
EventDB Period (Main Study Cohort): PamrevlumabDB Period (Main Study Cohort): PlaceboDB Period (Japan Extension Cohort)PamrevlumabDB Period (Japan Extension Cohort): PlaceboOLE Period: Pamrevlumab/PamrevlumabOLE Period: Placebo/Pamrevlumab
Idiopathic pulmonary fibrosisRespiratory, thoracic and mediastinal disorders19/18117/1751/187/197/1297/123
COVID-19Infections and infestations22/18116/1755/182/1914/12911/123
DiarrhoeaGastrointestinal disorders10/18111/1754/184/198/1295/123
CoughRespiratory, thoracic and mediastinal disorders37/18125/1753/182/1911/12914/123
NasopharyngitisInfections and infestations10/1816/1751/183/196/1293/123
BronchitisInfections and infestations14/18114/1750/180/1915/1299/123
ProctalgiaGastrointestinal disorders0/1810/1752/180/190/1290/123
Infusion site erythemaGeneral disorders0/1810/1752/180/190/1290/123
Oropharyngeal painRespiratory, thoracic and mediastinal disorders2/1811/1752/181/192/1291/123
Sputum increasedRespiratory, thoracic and mediastinal disorders2/1813/1752/180/192/1290/123

Baseline characteristics

The intent-to-treat (ITT) population included all randomized participants.

Age, Customized
Age, Customized(Participants)DB Period (Main Study Cohort): PamrevlumabDB Period (Main Study Cohort): PlaceboDB Period (Japan Extension Cohort): PamrevlumabDB Period (Japan Extension Cohort): PlaceboTotal
≤64 Years41283577
65 - 74 Years7794105186
≥75 Years635359130
Sex: Female, Male
Sex: Female, Male(Participants)DB Period (Main Study Cohort): PamrevlumabDB Period (Main Study Cohort): PlaceboDB Period (Japan Extension Cohort): PamrevlumabDB Period (Japan Extension Cohort): PlaceboTotal
Female494953106
Male1321261316287
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)DB Period (Main Study Cohort): PamrevlumabDB Period (Main Study Cohort): PlaceboDB Period (Japan Extension Cohort): PamrevlumabDB Period (Japan Extension Cohort): PlaceboTotal
Hispanic or Latino54440098
Not Hispanic or Latino1271311819295
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)DB Period (Main Study Cohort): PamrevlumabDB Period (Main Study Cohort): PlaceboDB Period (Japan Extension Cohort): PamrevlumabDB Period (Japan Extension Cohort): PlaceboTotal
American Indian or Alaska Native00000
Asian63691819169
Native Hawaiian or Other Pacific Islander00000
Black or African American01001
White11710400221
More than one race00000
Unknown or Not Reported11002
Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC)(liters)DB Period (Main Study Cohort): PamrevlumabDB Period (Main Study Cohort): PlaceboDB Period (Japan Extension Cohort): PamrevlumabDB Period (Japan Extension Cohort): PlaceboTotal
Main Study Cohort2.3668 ± 0.61852.4161 ± 0.6453——2.3911 ± 0.6314
Japan Extension Cohort——2.5864 ± 0.55212.5486 ± 0.51532.5670 ± 0.5264
08

Study locations

125 sites
  • University of Alabama at Birmingham Hospital
    Birmingham, Alabama 35294, United States
  • Banner University Medical Center - Phoenix
    Phoenix, Arizona 85006, United States
  • Norton Thoracic Institute
    Phoenix, Arizona 85013, United States
  • Pulmonary Associates, PA - Research
    Phoenix, Arizona 85032, United States
  • University of Arizona
    Tucson, Arizona 85724, United States
  • J&L Research
    Conway, Arkansas 72032, United States
  • Loma Linda University Health
    Loma Linda, California 92354, United States
  • David Geffen School of Medicine at UCLA
    Los Angeles, California 90095, United States
  • UC Davis Medical Center
    Sacramento, California 95817, United States
  • University of California San Diego
    San Diego, California 92103, United States
  • Stanford University Medical Center
    Stanford, California 94305, United States
  • University of Colorado Denver
    Aurora, Colorado 80045, United States
  • National Jewish Health
    Denver, Colorado 80207, United States
  • Yale University School of Medicine
    New Haven, Connecticut 06510, United States
  • Medstar Georgetown University Hospital
    Washington, District of Columbia 20007, United States
  • St. Francis Medical Center
    Clearwater, Florida 33765, United States
  • University of Florida Pulmonary, Critical Care & Sleep Medicine Division
    Gainesville, Florida 32610, United States
  • University of Florida Health, Jacksonville
    Jacksonville, Florida 32209, United States
  • Mayo Clinic
    Jacksonville, Florida 32224, United States
  • Pulmonary Disease Specialist, PA d/b/a, PDS Research
    Kissimmee, Florida 34741, United States
  • University of South Florida
    Tampa, Florida 33606, United States
  • Emory University
    Atlanta, Georgia 30322, United States
  • Piedmont Healthcare, Inc.
    Austell, Georgia 30106, United States
  • Northwestern University
    Chicago, Illinois 60612, United States
  • Loyola University of Chicago
    Maywood, Illinois 60153, United States
  • Indiana University School of Medicine
    Indianapolis, Indiana 46202, United States
  • The University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
  • University of Maryland, Baltimore
    Baltimore, Maryland 21201, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • Spectrum Health
    Grand Rapids, Michigan 49546, United States
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • The Lung Research Center, LLC
    Chesterfield, Missouri 63017, United States
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
  • Albany Medical College
    Albany, New York 12208, United States
  • Pulmonary Health Physicians, PC
    Liverpool, New York 13088, United States
  • Pulmonix, LLC
    Greensboro, North Carolina 27403, United States
  • University of Cincinnati
    Cincinnati, Ohio 45267, United States
  • Ohio State University
    Columbus, Ohio 43221, United States
  • INTEGRIS Baptist Medical Center
    Oklahoma City, Oklahoma 73112, United States
  • Legacy Research Institute
    Portland, Oregon 97210, United States
  • The Oregon Clinic
    Portland, Oregon 97220, United States
  • Penn State Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
  • Temple University
    Philadelphia, Pennsylvania 19140, United States
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
  • Lowcountry Lung and Critical Care, PA
    Charleston, South Carolina 29406, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • Tennessee Comprehensive Lung and Sleep Center
    Hendersonville, Tennessee 37075, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37204, United States
  • Houston Pulmonary Sleep, Allergy and Asthma Associates
    Cypress, Texas 77429, United States
  • Baylor Scott and White Research Institute
    Dallas, Texas 75246, United States
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • University of Texas - Houston
    Houston, Texas 77030, United States
  • UT Health San Antonio
    San Antonio, Texas 78229, United States
  • Renovatio Clinical
    The Woodlands, Texas 77380, United States
  • University of Utah Health
    Salt Lake City, Utah 84108, United States
  • The University of Vermont
    Burlington, Vermont 05405, United States
  • University of Washington
    Seattle, Washington 98195, United States
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
  • Fundacion Respirar - Centro Médico Dra. De Salvo
    Ciudad Autonoma De Buenos Aires (caba), Buenos Aires 1426, Argentina
  • Centro de Investigacion Metabolica 'CINME'
    Ciudad Autonoma de Buenos Aires, Buenos Aires C1027AAP, Argentina
  • Consultorios Medicos. Organización del Buen Ayre. SRL
    Ciudad Autonoma de Buenos Aires, Buenos Aires C1425FVH, Argentina
  • Centro Medico de Enfermedades Respiratorias
    Florida, Buenos Aires B1602DQD, Argentina
  • Centro Platense en Investigaciones Respiratorias
    La Plata, Buenos Aires 1900, Argentina
  • Instituto ave Pulmo Fundacion enfisema
    Mar del Plata, Buenos Aires B7602DCK, Argentina
  • INSARES
    Ciudad de Mendoza, Mendoza M5500CCG, Argentina
  • Respira Salud Clinica Integral
    Godoy Cruz, Provincia De Mendoza M5501GCA, Argentina
  • Investigaciones en Patologias Respiratorias
    San Miguel De Tucumán, Tucumán T4000IAR, Argentina
  • Royal Prince Alfred Hospital
    Sydney, New South Wales 2050, Australia
  • Westmead Hospital
    Westmead, New South Wales 2145, Australia
  • Mater Health Services Adult Hospital
    South Brisbane, Queensland 4101, Australia
  • Royal Adelaide Hospital
    Adelaide, South Australia 5000, Australia
  • Box Hill Hospital
    Box Hill, Victoria 3128, Australia
  • The Alfred Hospital
    Melbourne, Victoria 3004, Australia
  • Centro Investigacion del Maule CIM
    Talca, Region Del Maule 3465586, Chile
  • Instituto Nacional del Torax
    Santiago, Region Metropolitana 7500691, Chile
  • CIMER
    Santiago, Region Metropolitana 7500692, Chile
  • M y F estudios clinicos
    Santiago, Region Metropolitana 7750495, Chile
  • Second Affiliated Hospital of Anhui Medical University
    Hefei, Anhui 230000, China
  • BeiJing Chao-Yang Hospital,Capital medical university
    Beijing, Beijing 100020, China
  • China-Japan friendship hospital
    Beijing, Beijing 100029, China
  • Peking Union Medical College Hospital
    Beijing, Beijing 100730, China
  • Nanfang Hospital of Southern Medical University
    Guangzhou, Guangdong 510000, China
  • The First Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong 510120, China
  • Shenzhen people's hospital
    Shenzhen, Guangdong 518020, China
  • Henan Provincial People's Hospital
    Zhengzhou, Henan 450000, China
  • Henan Provincial chest hospital
    Zhengzhou, Henan 450003, China
  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
    Wuhan, Hubei 430022, China
  • Union Hospital,Tongji Medical College of Huazhong University of Science and Technology
    Wuhan, Hubei 430022, China
  • The Second Xiangya Hospital of Central South University
    Changsha, Hunan 410011, China
  • Affiliated Hospital of Inner Mongolia Medical University
    Hohhot, Inner Mongolia 10010, China
  • People's Hospital of Inner Mongolia Autonomous Region
    Hohhot, Inner Mongolia 10020, China
  • The second hospital of Dalian medical university
    Dalian, Liaoning 116001, China
  • The First Hospital of China Medical University
    Shenyang, Liaoning 110001, China
  • General Hospital of Ningxia Medical University
    Yinchuan, Ningxia 750004, China
  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai 200025, China
  • The Second Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shanxi 710004, China
  • Huaxi Hospital of Sichuan University.
    ChenDu, Sichuan 6100141, China
  • General Hospital of Tianjin Medical University
    Tianjin, Tianjin 300052, China

Showing the first 100 of 125 sites across 9 countries. Choose a country and city above to see the rest.

09

References and documents

Publications

  • Rayego-Mateos S, Morgado-Pascual JL, Lavoz C, Rodrigues-Diez RR, Marquez-Exposito L, Tejera-Munoz A, Tejedor-Santamaria L, Rubio-Soto I, Marchant V, Ruiz-Ortega M. CCN2 Binds to Tubular Epithelial Cells in the Kidney. Biomolecules. 2022 Feb 3;12(2):252. doi: 10.3390/biom12020252. PubMed 35204752 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2019 to primary completion in Mar 2023, 45 months.

Results were first posted in Sep 2024, 1 year 5 months after primary completion. A results delay was requested in Mar 2024.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2019
First posted
May 17, 2019
StartActual
Jun 18, 2019
Primary completionActual
Mar 20, 2023
CompletionActual
Aug 28, 2023
Results delay requested
Mar 15, 2024
Results first posted
Sep 19, 2024
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03955146
Lead sponsor
FibroGen
Responsible party
Sponsor
First posted
May 17, 2019
Start date
Jun 18, 2019
Primary completion
Mar 20, 2023
Completion
Aug 28, 2023
Results posted
Sep 19, 2024
Last update
Sep 19, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Pamrevlumab

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